With the increase in awareness and quality control on the process, the in vitro diagnostic quality control market expects good growth in the next decade; according to a research conducted by Kenneth Research

 The number of tests conducted in US was almost 1.5 million for 2013, and the number grew tremendously for 2014 i.e., 422 million worldwide; according to the data given by International Diabetes Federation (IDF). This ever-increasing number is giving a boost to in vitro diagnostic quality control market and expected to do so in the upcoming decade as well.

The global in vitro diagnostic quality control market is estimated to be worth nearly one billion US dollars and is expected to grow at a compound annual growth rate of 5% during the forecast period from 2022-2030. The presence of more and more accredited clinical laboratories and supporting regulatory agencies around the world is expected to be a key factor driving market growth. Due to the high incidence of diabetes, cardiovascular disease (CVD) and infectious diseases, diagnostic laboratories are developing rapidly. Many public and private laboratories are undergoing laboratory certification procedures to comply with industry standards, increase the number of procedures, and attract more patients.

CLIA accredited laboratories are eligible for reimbursement through Medicare and Medicaid services. Regulatory agencies that oversee the quality control and regular quality control of IVD equipment and service providers include the United States Medicines and Healthcare Products Regulatory Agency (MHRA) FDA; Therapeutic Goods Administration of Australia (TGA) (TGA); Central Drug Standards Control Organization of India (CDSCO) ); Health Canada is Canada; European Medicines Agency (EMEA) Europe; Ministry of Health, Labour and Welfare (MHLW) of Japan; Ministry of Health, Labour and Welfare (MHLW) of Brazil; and Ministry of Health of South Africa.

Major market players:

Siemens Healthcare GmbH; Roche Diagnostics; Alere, Inc.; Abbott Laboratories Co., Ltd.; Biotechnology; Hologic, Inc. (Gen-Probe); Qiagen NV; Bio-Rad Laboratories; Quaidell; Becton, Dickinson and Company (BD); BioMérieux; Sysmex; Serum AS; and Thermo Fisher Scientific, Inc.

The United States is the main region of the North American market in 2018 and will maintain its dominant position in the next few years. The strong presence of the country’s major companies is one of the important factors in sustaining this growth. In addition, regulatory agencies such as the US FDA and the Global Harmonization Task Force (GHTF) are promoting the integration of the medical device regulatory system, which is expected to promote trade through regulatory measures while protecting public health. To ensure that the results provided to the patient are accurate. These verifications are usually performed during instrument installation, after maintenance, reagent batch replacement, and when instrument readings are out of range.

The agencies that manage the quality of these IVDs include the European Federation of Clinical Chemistry and Laboratory Medicine (EC4). The American Laboratory Accreditation Association (A2LA) and the Clinical Laboratory Improvement Amendment (CLIA) have increased the need for IVD quality control. During the forecast period, home care is expected to become the fastest growing end-use market segment. The home care environment includes a variety of equipment such as self-assessment kits, point-of-care (POC) kits for bedside testing, and IVD kits in assisted medical environments. The self-assessment kit provides convenience for patients who need daily checkups and further reduces the number of visits.

Home care products include diabetes blood glucose monitoring kits, pregnancy test kits/kits, urine analyzers, hemoglobin sensors and home hormone tests. Since non-professionals use these devices, there is a high risk. Perform quality control and assurance before and after the launch of these devices to ensure patient safety.

Main market regions:

The study on in vitro diagnostic quality control market was global in nature and conducted in North America (U.S., Canada), Europe (U.K., Germany, France, Italy, Spain, Hungary, Belgium, Netherlands & Luxembourg, NORDIC, Poland, Turkey, Russia, Rest of Europe), Latin America (Brazil, Mexico, Argentina, Rest of Latin America), Asia-Pacific (China, India, Japan, South Korea, Indonesia, Malaysia, Australia, New Zealand, Rest of Asia-Pacific), Middle East and Africa (Israel, GCC (Saudi Arabia, UAE, Bahrain, Kuwait, Qatar, Oman), North Africa, South Africa, Rest of Middle East and Africa). In addition, areas like Market size, Y-O-Y growth & Opportunity Analysis, market players competitive study, investment opportunities, demand for future outlook etc. have been covered and displayed in the Global in vitro diagnostic quality control market research report to ensure it dives deep to achieve strategic competitive intelligence in the segment.